K043386 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 7, 2005, 60 days after receiving the submission on December 9, 2004.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K043386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2004 |
| Decision Date | February 07, 2005 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LEH — Radioimmunoassay, Vancomycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3950 |